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Revision No. : 00
Code : 01026
: PRO-ST/BRC/MB/087-SB; Rev. 00, PRO-
MS No.
ST/BRC/MB/088-SB; Rev. 00
Prepared by:
SUMMARY
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TABLE OF CONTENTS
\\Cimareme\Release\Caprifarmindo\Validation\ Protocol\VAL-PV/PVP/MB/068 – Sanmol Forte Tablet Process Validation Protocol - R00.doc
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SUMMARY.......................................................................................................................................2
1. OBJECTIVE................................................................................................................................5
2. SCOPE.........................................................................................................................................5
3. VALIDATION TEAM..................................................................................................................5
3.1. Team Member.....................................................................................................................5
3.2. Responsibilities...................................................................................................................5
3.2.1. Production Department...........................................................................................5
3.2.2. QC Department.......................................................................................................6
3.2.3. QA Department.......................................................................................................6
3.2.4. Validation Department............................................................................................6
3.2.5. R&D Department....................................................................................................6
3.2.6. Engineering Department.........................................................................................6
3.2.7. PPIC Department....................................................................................................7
4. PROCESS VALIDATION STAGE..............................................................................................7
4.1. Responsible Personel..........................................................................................................7
4.2. Starting Material..................................................................................................................7
4.2.1. Formula...................................................................................................................7
4.2.2. Specification & Test Procedure Number of Raw Material.....................................7
4.2.3. Specification & Test Procedure Number of Packaging Product.............................8
4.2.4. Specification & Test Procedure Number Finished Product.....................................8
4.2.5. Machines/ Equipments............................................................................................8
4.3. Room Condition..................................................................................................................8
4.4. Process Schematic Flow......................................................................................................9
4.5. Production Process, Critical Parameter, Testing Point and Analysis Method...................13
4.6. Sampling Plan...................................................................................................................13
4.6.1. Sampling in FBD Jaw Chuang..............................................................................13
4.6.2. Sampling in Super Mixer SM-150........................................................................14
4.6.3. Sampling During Tablet Pressing..........................................................................14
4.6.4. Sampling during Stripping....................................................................................15
4.7. Acceptance Criteria............................................................................................................16
5. CONCLUSION OF THE PROCESS VALIDATION................................................................16
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6. DISCUSSION...........................................................................................................................16
7. RECOMMENDATION.............................................................................................................16
8. DECISION................................................................................................................................16
9. PROPOSE OF REVALIDATION.............................................................................................16
10. LIST OF ENCLOSURE............................................................................................................16
11. DEVIATION REPORT..............................................................................................................17
12. REVISION HISTORY...............................................................................................................17
1. OBJECTIVE
The aim of this validation is to ensure that the production process of SANMOL FORTE
Tablet base on the batch record for 120 kg batch size (batch size increased from 20 kg to
120 120 kg) will produce high degree quality product consistently.
2. SCOPE
This validation is dedicated for SANMOL FORTE Tablet that toll manufacturing product
from PT. Sanbe Farma to PT. Caprifarmindo Laboratories, Cimareme, Padalarang.
The scope of this validation for SANMOL FORTE Tablet covers mixing, granulating,
drying, compressing and stripping.
The validation process will be performed concurrently. This protocol is not allowed to be
change during execution.
3. VALIDATION TEAM
3.1. Team Member
3.2. Responsibilities
3.2.1. Production Department
Responsible for:
1. Preparing and maintaining the departmental procedures and operator
training programs, which are necessary to ensure that the developed and
implemented standards in the validation runs are followed properly during
routine production.
2. Ordering and maintaining adequate supplies of raw materials and packaging
components to be used for the validation process runs.
3. Preparation, set up and operation of machine and other necessary
production equipment and utensil.
4. Implementing any agreed recommendations that may be made as results of
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this study.
5. Conducting environmental monitoring of temperature and relative humidity
during validation process activity together with validation department.
3.2.2. QC Department
Responsible for:
1. Preparing all sampling and testing equipment.
2. Testing the samples according to validated analytical method.
3. Conducting investigation with production and validation if there is any out
of specification case.
4. Taking sample according to the sampling point mentioned in this protocol.
3.2.3. QA Department
1. Reviewing and approving validation protocol and report for SANMOL
FORTE Tablet.
2. Ensuring that cleaning validation activities conform with quality assurance
requirements.
3.2.4. Validation Department
Responsible for:
1. Preparing validation protocol and report for SANMOL FORTE Tablet.
2. Conducting validation process activities together with the designated
validation team members from Production, QC, R&D and Engineering
departments.
3. Conducting environmental monitoring of temperature and relative humidity
during validation process activity together with production department.
4. Conducting investigation with R&D, production and QC if there is any out
of specification case.
5. Ensuring that the validation process is executed as approved protocol
agreed.
3.2.5. R&D Department
Responsible for:
1. Preparing the batch record for SANMOL FORTE Tablet.
2. Preparing the product specification and analysis method.
3. Conducting investigation with Validation, production and QC if there is any
out of specification case.
3.2.6. Engineering Department
Responsible for:
1. Preparing all instruments and equipment needed in the validation process.
2. Preparing and maintaining required standard production operating
conditions and utilities.
3. Repairing and trouble shooting equipment/instrument in case of breakdown
or malfunction.
3.2.7. PPIC Department
Responsible for:
1. Preparing production planning includes validation batches.
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PL = Polycellonium
PT = Plain Transparant
4.5. Production Process, Critical Parameter, Testing Point and Analysis Method
Croscarmellose
Sodium (3.600 kg) Sieving (2E) Granulator Screen 2 mm
Talc (1.200 kg) Jaw Chuang
OG
Silicon Dioxide
Colloidal (2.400 kg)
Magnesium Stearate
Sieving (2F) Stainless Mesh 30
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Preservatives Solution
preparation
Hot Purified Water 24
Liter
Methylparaben
(0.084 kg)
Propylparaben
(0.036 kg)
Mixed material Wet granulating Super Granulating 1 Good wet masses Visually
step 3 (5) Mixer Agitator
Mucilage from (SM-150) speed :
step 4
95 – 98 rpm
Chopper
speed :
450 – 460
rpm
Time : 10
minutes
Granulating 2
Agitator
Purified Water 3 Liter speed :
95 – 98 rpm
Chopper
speed :
450 – 460
rpm
Time : 5
minutes
Granulating 3
Agitator
Purified Water speed :
3 Liter 95 – 98 rpm
Chopper
speed :
820 – 840
rpm
Time : 5
minutes
D
B
C
E
H
F
G
I
10 tablets as samples for thickness test, weight uniformity and hardness testing
and marked “F”.
16 tablets as samples for friability and disintegration time and marked
“Middle”.
42 tablets as samples for assay, uniformity of dosage unit testing and
dissolution testing and marked ‘Middle”.
7. After tablet pressing machine produce 15,000 tablets, take samples:
10 tablets for thickness test, weight uniformity and hardness testing and
marked “G”.
8. After tablet pressing machine produce 17,500 tablets, take samples:
10 tablets for thickness test, weight uniformity and hardness testing and
marked “H”.
9. After tablet pressing machine produce 20,000 tablets, take samples:
10 tablets for thickness test, weight uniformity and hardness testing and
marked “I”.
10. After tablet pressing machine produce 22,500 tablets, take samples:
10 tablets as samples for thickness test, weight uniformity and hardness testing
and marked “J”.
16 tablets as samples for friability and disintegration time and marked “End”.
42 tablets as samples for assay, uniformity of dosage units testing and
dissolution testing and marked “End”.
6. DISCUSSION
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7. RECOMMENDATION
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8. DECISION
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9. PROPOSE OF REVALIDATION
Revalidation is performed if there is change of;
1. Formulation
2. Batch size (if more than 25 % of previous batch)
3. Manufacturing process
4. Equipment
5. Primary packaging material
Name of Validation:
Deviation description
Proposal to close the
deviation
Discussion and
conclusion
Reported by Reviewed by Approved by
( ) ( ) ( )
Revision
Date Description Originator
No.
00 09 September 2013 Initial Release Frisky Almuksiti